Actively Recruiting
A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer
Led by Light Chain Bioscience - Novimmune SA · Updated on 2024-10-29
25
Participants Needed
2
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study LCB-2301-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NILK-2301 in patients with locally advanced or metastatic low tumor volume (LTV) colorectal cancer. The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of NILK-2301 to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of NILK-2301 monotherapy. The expansion part (Part B) will further evaluate the safety and efficacy of NILK-2301 monotherapy administered at or below the MTD in up to 10 additional subjects in order to determine the recommended Phase 2 dose (RP2D). Treatments will be administered every two weeks in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator/patient decision to withdraw study consent.
CONDITIONS
Official Title
A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older at the time of informed consent
- Histologically or cytologically confirmed colorectal cancer
- Locally advanced or metastatic disease after at least one prior systemic treatment
- Failed, intolerant to, or not candidates for available therapies with known clinical benefit
- Measurable disease per RECIST 1.1 guidelines
- Tumor lesions totaling up to approximately 50 cc with sum of longest diameters less than 7 cm
- Any measurable lesion longest diameter less than or equal to 5 cm (excluding pathological lymph nodes)
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Laboratory values including ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors within 14 days), platelets ≥ 100 x 10^9/L (no transfusion support within 14 days), hemoglobin ≥ 10 g/dL
- Potassium levels within normal limits or correctable
- AST and ALT ≤ 2.5 times upper limit of normal, ALP ≤ 3 times upper limit of normal
- Serum bilirubin less than 1.5 times upper limit of normal
- Calculated glomerular filtration rate ≥ 45 mL/min/1.73 m^2
- INR less than 1.5 times upper limit of normal and PTT less than 1.5 times upper limit of normal
- Females of childbearing potential must have negative pregnancy tests before treatment and agree to use effective birth control during and for 28 days after treatment
You will not qualify if you...
- Known hypersensitivity to NILK-2301 or its components
- Presence of central nervous system lesions or bone disease
- Presence of pleural or pericardial tumor lesions
- Radiotherapy to target lesions within 4 weeks before first infusion
- Anti-cancer therapy within 28 days before starting NILK-2301 (except low dose steroids ≤ 10 mg prednisone equivalent, localized non-CNS radiotherapy to non-target lesions, bisphosphonates, or RANKL inhibitors)
- Participation in other investigational therapies during the study; COVID-19 vaccination allowed only from Cycle 2
- Severe cardiac dysfunction (NYHA class III-IV)
- Significant liver dysfunction (bilirubin ≥ 1.8 mg/dL or AST/ALT ≥ 2.5 times ULN, ALP > 3 times ULN)
- Known HIV infection or serological evidence of hepatitis B or C
- Active uncontrolled infection or intravenous anti-infective treatment within 2 weeks before first dose
- History or current autoimmune disease requiring permanent immunosuppression (low-dose steroids ≤ 10 mg/day allowed)
- Concomitant active malignancy requiring treatment
- CNS metastases, leptomeningeal disease history, or seizure disorders requiring therapy
- ANC less than 1 x 10^9/L without colony stimulating factors within 14 days
- Pregnancy or lactation
- Psychiatric illness or substance abuse interfering with consent or protocol compliance
- Significant medical conditions increasing study risk including recent myocardial infarction, unstable angina, uncontrolled diabetes, severe immunocompromise, or major surgery within 4 weeks
- Acute toxic effects from prior therapies not resolved to Grade ≤1 except alopecia, anemia, and peripheral neuropathy (Grade ≤2 acceptable)
- Live or live attenuated vaccine within 28 days before consent
- Prior treatment with CEACAM5 targeting agents
- Prior treatment with T-cell bispecific antibodies or CAR T-cell therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
2
START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid, Spain
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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